Warning

All products:

This drug is a strong pain drug that can put you at risk for addiction, abuse, and misuse. Misuse or abuse of this drug can lead to overdose and death. Talk with your doctor.

You will be watched closely to make sure you do not misuse, abuse, or become addicted to this drug.

This drug may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.

The chance of very bad and sometimes deadly breathing problems may be greater when you first start this drug or anytime your dose is raised.

Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.

Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.

This drug has an opioid drug in it. The use of opioid drugs along with a benzodiazepine drug or other drugs that may make you drowsy or slow your actions has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and deaths. Benzodiazepine drugs include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepine drugs are used to treat many health problems like anxiety, trouble sleeping, or seizures. Talk with the doctor.

Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.

Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen.

Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.

Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.

Long-acting products:

Swallow whole. Do not chew, break, crush, or melt before swallowing. Doing these things can cause very bad side effects and death.

Long-acting and liquid products:

Make sure you have the right drug; there is more than one strength. A lower strength may not ease pain well enough. A higher strength could lead to accidental overdose and death.

Certain strengths of this drug may only be used by people who have been taking drugs like this drug and are used to their effects. The use of these strengths by people who have not been taking drugs like this drug may cause very bad and sometimes deadly breathing problems. Talk with the doctor.

What is this drug used for?

Long-acting products:

It is used to ease very bad pain.

It is only to be used when around-the-clock (continuous) care is needed for a long time. It is also only to be used when other pain drugs do not treat your pain well enough or you cannot take them.

All other products:

It is used to ease pain.

What do I need to tell my doctor BEFORE I take this drug?

If you have an allergy to this drug or any part of this drug.

If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

If you have any of these health problems: Very bad lung problems like asthma or trouble breathing, high levels of carbon dioxide in the blood, or stomach or bowel block or narrowing.

If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson’s disease like selegiline or rasagiline in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.

If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.

If you are breast-feeding. Do not breast-feed while you take this drug.

This is not a list of all drugs or health problems that interact with this drug.Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

All products:

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.

Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.

To lower the chance of feeling dizzy or passing out, rise slowly over a few minutes when sitting or lying down. Be careful climbing stairs.

Do not take this drug with other strong pain drugs or if you are using a pain patch without talking to your doctor first.

Have your blood work checked if you are on this drug for a long time. Talk with your doctor.

Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.

If you are 65 or older, use this drug with care. You could have more side effects.

If you have been taking this drug for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this drug stops working well. Do not take more than ordered.

Long-term use of an opioid drug like this drug may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.

Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.

Long-acting products:

Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.

Long-acting tablets:

For some brands, you may see the tablet shell in your stool. For these brands, this is normal and not a cause for concern. If you have questions, talk with your doctor.

All other products:

If you have been taking this drug on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking this drug all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.

Injection:

If you are allergic to sulfites, talk with your doctor. Some products have sulfites.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Very bad dizziness or passing out.

Chest pain or pressure or a fast heartbeat.

Trouble breathing, slow breathing, or shallow breathing.

Noisy breathing.

Seizures.

Very hard stools (constipation).

Feeling very tired or weak.

Feeling very sleepy.

Mood changes.

A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this drug with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.

Taking an opioid drug like this drug may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Feeling sleepy.

Dizziness.

Dry mouth.

Upset stomach or throwing up.

Hard stools (constipation).

Headache.

Anxiety.

Feeling tired or weak.

Belly pain.

Sweating a lot.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.You may report side effects to your national health agency.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All oral products:

Take with or without food. Take with food if it causes an upset stomach.

Do not inject or snort this drug. Doing any of these things can cause very bad side effects like trouble breathing and death from overdose.

Long-acting products:

To gain the most benefit, do not miss doses.

Take this drug at the same time of day.

Swallow whole. Do not chew, break, crush, or melt before swallowing. Doing these things can cause very bad side effects and death.

Do not use for fast pain relief or on an as needed basis.

Do not use for pain relief after surgery if you have not been taking drugs like this drug.

Long-acting tablets:

Do not put this drug down a feeding tube.

Long-acting capsules:

If you cannot swallow this drug whole, you may sprinkle the contents on applesauce. If you do this, swallow the mixture right away without chewing.

Rinse mouth to make sure all contents have been swallowed.

Some brands of this drug may be given down a certain type of feeding tube. Other brands must not be given down a feeding tube. Check with your pharmacist to see if you can give this drug down a feeding tube.

Liquid (solution):

Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.

Liquid (concentrate):

Measure liquid doses carefully. Use the measuring device that comes with this drug.

Suppository:

Use suppository rectally.

Wash your hands before and after use.

If suppository is soft, chill in a refrigerator or run cold water over it.

Take foil off the rectal suppository and put in, pointed end first. Do not handle too much.

Wet suppository before putting in rectum.

Injection:

It is given as a shot into a muscle, vein, or into the fatty part of the skin.

What do I do if I miss a dose?

Short-acting products:

If you take this drug on a regular basis, take a missed dose as soon as you think about it.

If it is close to the time for your next dose, skip the missed dose and go back to your normal time.

Do not take 2 doses at the same time or extra doses.

Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.

Long-acting products:

Skip the missed dose and go back to your normal time.

Do not take 2 doses at the same time or extra doses.

Injection:

Call your doctor to find out what to do.

How do I store and/or throw out this drug?

Oral products and suppository:

Store at room temperature.

Protect from light.

Store in a dry place. Do not store in a bathroom.

Injection:

If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.

All products:

Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.

Check with your pharmacist about how to throw out unused drugs.

General drug facts

If your symptoms or health problems do not get better or if they become worse, call your doctor.

Do not share your drugs with others and do not take anyone else’s drugs.

Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.

Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.

Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Last Reviewed Date

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If you have any questions or concerns, contact a member of your healthcare team directly or call 212-639-2000 for help.

If you have any questions or concerns, talk with a member of your healthcare team. You can reach them Monday through Friday from 9:00 am to 5:00 pm at ____________________. After 5:00 pm, during the weekend, and on holidays, please call____________________. If there’s no number listed, or you’re not sure, call 212-639-2000.